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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000034551
Receipt No. R000039387
Scientific Title An investigation study of measuring the glycemic index (GI): non-randomized single administration study
Date of disclosure of the study information 2018/10/17
Last modified on 2019/03/31

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Basic information
Public title An investigation study of measuring the glycemic index (GI): non-randomized single administration study
Acronym An investigation study of measuring the glycemic index (GI)
Scientific Title An investigation study of measuring the glycemic index (GI): non-randomized single administration study
Scientific Title:Acronym An investigation study of measuring the glycemic index (GI)
Region
Japan

Condition
Condition Healthy Japanese subjects
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To measure the glycemic index (GI) of the test food
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes GI

* Based on ISO 26642
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Duration: single dose
Test Material: test food
Dose: 204 g (50g of carbohydrate amount)
Administration: Eat the test food with water (300 mL) within 12-15 minutes

Duration: single dose
Test Material: 50 g of glucose solution
Dose: 150 mL
Administration: Take the solution within 12-15 minutes
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
50 years-old >=
Gender Male and Female
Key inclusion criteria 1. Healthy Japanese adult subjects ages between 20-50 years
2. Subjects who are below 30 kg/m2 in BMI
3. Subjects who are judged as eligible to participate in the study by the physician
Key exclusion criteria 1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure or myocardial infarction
2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD)
3. Currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disease, kidney disease, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases
4. Subjects who have food allergies and/or food intolerances
5. Subjects who take medications known to affect glucose tolerance
6. Subjects who use insulin to treat diabetes or take antihyperglycemic drugs
7. subjects who are the presence of disease or drugs which influence digestion and absorption of nutrients
8. Subjects who use or take "Foods for Specified Health Uses", "Foods with Function Claims", or other functional food/beverage in daily
9. Subjects who are currently taking medications (including herbal medicines) and dietary supplement. Particularly, the use of steroids, protease inhibitors, or antipsychotics
10. Subjects who are an allergic reaction to medications and/or the test food related products. Particularly, the presence of celiac disease or sensitive to gluten
11. Subjects who are pregnant, breast-feeding, or planning to become pregnant
12. Subjects who have a major medical or surgical event requiring hospitalization within the preceding 3 months
13. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial or plan to enroll in anther clinical trials during trial period
14. Subjects who are judged as ineligible to participate in the study by the physician
Target sample size 10

Research contact person
Name of lead principal investigator
1st name Kazuo
Middle name
Last name YAMAMOTO
Organization ORTHOMEDICO Inc.
Division name CEO
Zip code 112-0002
Address 2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
TEL 03-3818-0610
Email kazu@orthomedico.jp

Public contact
Name of contact person
1st name Naoko
Middle name
Last name SUZUKI
Organization ORTHOMEDICO Inc.
Division name R&D Department
Zip code 112-0002
Address 2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
TEL 03-3818-0610
Homepage URL
Email nao@orthomedico.jp

Sponsor
Institute ORTHOMEDICO Inc.
Institute
Department

Funding Source
Organization TEIJIN LIMITED
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Medical Corporation Seishinkai, Takara Clinic
Name of secondary funder(s)

IRB Contact (For public release)
Organization the ethical committee of the Takara Clinic, Medical Corporation Seishinkai
Address 9F Taisei Building, 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan.
Tel 03-5793-3623
Email info@takara-clinic.com

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 医療法人社団盛心会 タカラクリニック (東京都)
Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)

Other administrative information
Date of disclosure of the study information
2018 Year 10 Month 17 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled 11
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2018 Year 10 Month 12 Day
Date of IRB
2018 Year 10 Month 12 Day
Anticipated trial start date
2018 Year 10 Month 18 Day
Last follow-up date
2018 Year 12 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 10 Month 17 Day
Last modified on
2019 Year 03 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039387

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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